Blood pump system user interface alarm management

ABSTRACT

User interfaces for medical perfusion systems that provide oxygenation, filtering, and recirculation of blood in connection with various medical procedures are provided. In particular, user interfaces for use with blood pumps that assist in managing alarms commonly encountered during cardiopulmonary bypass surgeries are provided.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority to U.S. Provisional ApplicationNo. 60/905,640, filed Mar. 8, 2007, the entire contents of which areincorporated herein by reference.

TECHNICAL FIELD

The present invention is directed to user interfaces for medicalperfusion systems that provide oxygenation, filtering, and recirculationof blood in connection with various medical procedures. In particular,the present invention is directed to user interfaces for use with bloodpumps that assist in managing alarms commonly encountered duringcardiopulmonary bypass surgeries.

BACKGROUND

Conventional perfusion systems are used to oxygenate, filter, and/orrecirculate the blood of a patient during a medical procedure such asduring cardiopulmonary surgeries. Such perfusion systems include a fluidconduit that removes blood from the patient during the medicalprocedure, a separate fluid conduit that returns blood to the patient,one or more blood pumps that pump blood through the conduits, and aplurality of sensing devices, such as flow sensors and/or level sensorsassociated with blood pumps. The perfusion system may also include airembolus sensors, temperature sensors, flow occluders, etc.

Perfusion systems require a perfusionist operating the perfusion systemto closely monitor many different parameters, and manually adjust thespeeds of the various pumps in the system on a frequent basis to keepthe various parameters in balance and within safe and desired limits.Alarm conditions, when they occur, require immediate, manual action bythe perfusionist. Accordingly, mechanisms are needed to help theperfusionist safely, accurately, and quickly manage such alarmconditions control the perfusion system with greater safety, accuracyand speed.

SUMMARY

The present invention provides unique user interface designs thatannunciates an alarm condition, describes the nature of the alarm withindicia such as text, and provides the user with options concerning howto best manage the alarm condition. Clear visual indicators are providedto assist in managing the device and handling the alarm condition. Forexample, visual indicators may use the colors red and yellow to guidethe user to quickly manage the machine interface during the managementof alarms.

In an aspect of the present invention, a method of managing an alarmcondition of a perfusion system during cardiopulmonary bypass surgery isprovided. The method comprises the steps of providing a user interfacefor the perfusion system comprising a touch screen, displaying a colorcoded alarm condition on the touch screen, and displaying a color codedalarm management icon on the touch screen for managing the displayedcolor coded alarm condition.

In another aspect of the present invention, a user interface formanaging an alarm condition of a perfusion system during cardiopulmonarybypass surgery is provided. The user interface comprises a touch screen,a color coded alarm condition indicator displayed on the touch screencomprising a color coded graphical portion and a color coded textualmessage portion for providing information related to an alarm condition,one or more color-coded alarm management icons displayed on the displayscreen for managing the alarm condition based on the color coded alarmcondition indicator.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee. The accompanying drawings, which are incorporatedin and constitute a part of this application, illustrate several aspectsof the invention and together with description of the embodiments serveto explain the principles of the invention. A brief description of thedrawings is as follows:

FIG. 1 is a perspective view of an exemplary pump console according toan aspect of the present invention showing a user interface and a baseunit.

FIG. 2 is a schematic block diagram of the pump console of FIG. 1.

FIG. 3 is a schematic diagram of a safety module that can be used withthe base unit according to an aspect of the present invention.

FIG. 4 is an exemplary main screen of a user interface in accordancewith the present invention.

FIG. 5 is an exemplary settings screen of a user interface in accordancewith the present invention.

FIG. 6 illustrates a user interface in accordance with the presentinvention in a normal state of operation without an indication of analert or alarm condition.

FIG. 7 illustrates a user interface in accordance with the presentinvention showing an alert condition identified by a color coded statusbar and a color coded message box and showing color coded informationfor managing the alert condition.

FIG. 8 illustrates a user interface in accordance with the presentinvention showing an alarm condition identified by a color-coded statusbar and a color coded message box and showing color coded informationfor managing the alarm condition.

FIGS. 9 and 10 illustrate a user interface in accordance with thepresent invention showing another alarm condition identified by acolor-coded status bar and a color coded message box and showing colorcoded information for managing the alarm condition.

DETAILED DESCRIPTION

FIG. 1 is an exemplary perspective view and FIG. 2 is a schematic blockdiagram of a pump console 10 in accordance with the present invention.As shown, the pump console 10 comprises two primary components,including a base unit 12 and a user interface 14 that can communicatevia communication link 13. The pump console 10 may comprise astand-alone centrifugal pump control system or it may comprise an add-onmodule to commercially available heart-lung machines or blood pumps. Thebase unit 12 provides functionality for controlling pump speed,monitoring flow/pressure, battery backup, and providing communicationsto the user interface 14, for example. The user interface 14 includes adisplay 16 and user controls for operating and/or interfacing with theuser interface 14. Display 16 preferably comprises a touchdisplay/screen or other display device that allows input to be providedto an icon displayed on the screen by touching, contacting, or otherwiseidentifying the icon. Components of the base unit 12 and/or userinterface 14 preferably comprise microcontrollers that providecommunications through an asynchronous serial interface (RS232) orsuitable communications protocol.

As illustrated, the base unit 12 comprises plural functional modulesincluding a system controller module 18, motion/pressure module 20, flowmodule 22, and safety module 24. The safety module 24 is schematicallyshown in further detail in FIG. 3 and preferably comprises a safetymodule bus interface 41, system bus interface 26, watchdog timer 28, andmotor controller servo interface 30, which motor controller includesspeed control input 39 and speed control output 37. The safety module 24also preferably includes interfaces to safety systems such as a bubbledetector interface 32, level sensor interface(s) 34, and an arterialclamp interface 36, which comprise inputs 31, 33, and 35, respectively.The bubble detector interface 32 provides an alarm to the operator whenit detects the presence of bubbles or gross air in the tubing of theflow circuit. The level sensor interface(s) 34 provide an alarm or alertto the operator preferably based upon two separate level detectorsplaced on the patient blood reservoir. The arterial clamp interface 36provides automated arterial line occlusion in the event of retrogradeflow as determined by operator setup.

FIG. 4 illustrates an exemplary main screen 38 for the user interface 14in accordance with the present invention. In use, main screen 38, aswell as any other screen or screens of the user interface 14, aredisplayed on display 16 and are preferably capable of receiving touchinputs such as with a finger or appropriate stylus. Main screen 38 ispreferably configured to display information related to operatingparameters such as alert and alarm status, blood flow and pump speed,line pressure, user configurable timers, safety systems (if installed),and power status, for example.

An exemplary settings screen 40 of the user interface 14 is shown inFIG. 5. Settings screen 40 provides the capability to set parameterssuch as blood flow range and upper/lower alert/alarm limits, targetblood flow rate with cardiac index and height/weight calculator,pressure transducer zeroing and upper/lower alert/alarm limits, threetimer presets, and screen backlight intensity, for example.

User interface 14 preferably comprises a system status indicator 42positioned at the top of a desired user interface screen such as thoseshown in FIGS. 3, 8, 22, 26, and 27. System status indicator 42preferably comprises an optional color-coded status bar 44 and acolor-coded system status message box 46. The color coded status bar 44preferably uses three colored light bars 48, 50, and 52 that areassociated with the operation status of the system and provide a visualcue for assessing system status when lit. Preferably first, second, andthird colors such as green, yellow, and red are used for the light bars48, 50, and 52, respectively, however any desired colors can be used.The status bar 44 and message box 46, as shown, are preferablypositioned at the top of a screen but can be positioned anywhere on ascreen as desired. The intensity of the light bars 48, 50, and 52 aswell as any other color coded icon of the user interface can be variedto provide additional visual information such as the intensity of acondition, alert, or alarm.

The user interface 14 preferably uses distinct alarm/alert sounds oraudible signals to inform the user when alarm or alert conditions arepresent. An alarm sound preferably comprises a repeating sequence oflong and short beeps. An alarm condition is more serious than an alertcondition and requires a corrective action by the user. An alert soundpreferably comprises a steady paced beep.

In FIG. 6, user interface 14 is illustrated in a state of normaloperation. That is, no alert or alarm conditions are active. As shown,illumination of the green light bar 48 of the system status indicator 42indicates all systems are functioning normally and (as applicable)safety devices are enabled. In this normal state, light bars 50 and 52are unlit or colorless. Accordingly, no action is indicated or requiredto keep the system functioning normally in such system state.Additionally, the system status message box 46 displays informationabout the highest priority alert or alarm. The user interface 14 ispreferably pre-programmed so that alerts or alarms are prioritized.Preferably, the highest priority alert or alarm is displayed and whenthat alert or alarm is corrected the next highest alert or alarm isdisplayed, if any. In the normal state of operation and as illustratedin FIG. 6, the system status message box 46 is preferably displayedwithout a corresponding green color code although the system statusmessage box 46 may be color coded if desired. That is, message box 46can be white or grey, for example, or match the background color ofother screen elements as desired.

In FIG. 7, user interface 14 is illustrated in a state of malfunctionand with an indication of an alert. An alert indicates a condition otherthan normal operation and that requires attention by an operator. Inthis case, the state of malfunction is a flow-system malfunction. Analert notification preferably includes a steady paced beep or otheraudible signal and illumination of the yellow light bar 50 of the systemstatus indicator 42, as illustrated. Light bars 48 and 52 are preferablyunlit or colorless, as illustrated. Additionally, the system statusmessage box 46 displays information about the alert and is preferablydisplayed with a corresponding yellow color code. The system ispreferably configured so an alert or alarm condition is preferablytemporarily silenced by pressing the mute button 55, but will preferablyresume after 60 seconds if the condition is not resolved or if a newalert or alarm condition occurs. The mute button 55 preferably onlyappears when an alert or alarm condition exists and may be color-codedif desired.

The illustrated alert condition of FIG. 7 is a flow system malfunctionbut any desired condition can be characterized as an alert condition.Exemplary alert conditions include those related to a low reservoir,flow rate, pressure, and clamp air pressure. An alert conditionindicates a problem and typically requires a corrective action by theuser. The system status message box 46 identifies the alert conditionand also provides information regarding how to manage the alertcondition using the words “Press Service (Wrench) Button ToAcknowledge.” The alert condition can be managed by pressing the servicewrench button 54, which is also preferably color-coded, yellow with thealert condition color. Pressing the service wrench button 54 displays alog of internal system errors. An alert condition may display additionalunique yellow icons to aid the user in identifying the source of thealert condition. The user interface 14 thus provides an indication ofthe alert condition with the yellow light bar 50 and yellow coded systemstatus message box 46, indication of the particular alert condition andhow to manage the alert condition in the system status message box 46,and an indication of where to manage the alert condition on the touchscreen with the color coded icon (e.g., service wrench button 54). Anycombination of colors, color intensity, sounds, and text can be used inaccordance with the present invention to identify an alert condition.

In FIG. 8, user interface 14 is illustrated in a state of alarm and withan indication of such alarm. An alarm condition is more serious than analert condition and requires an immediate corrective action by the user.Exemplary alarm conditions relate to communications errors, bubbles inthe flow circuit, and motor or pump failure. An alarm notificationpreferably includes a repeating sequence of long and short beeps andillumination of the red light bar 52 of the system status indicator 42,as illustrated. Light bars 48 and 50 are preferably unlit or colorless,as illustrated. Additionally, the system status message box 46 displaysinformation about the alarm and is preferably displayed with acorresponding red color code. The illustrated alarm of FIG. 8 is relatedto detection of a bubble in the flow circuit, but any desired conditionof the perfusion system can be characterized as an alarm condition.Accordingly the system status message box 46 identifies the conditionand also provides information regarding how to manage the alarm with thewords “Press Bubble Detector Button To Acknowledge.” The alarm conditioncan be managed by pressing the service bubble detector button 56, whichis also preferably color coded red with the alarm color. An alarm maydisplay additional unique red icons to aid the user in identifying thesource of the alarm condition. Accordingly, like the alert conditiondescribed above relative to FIG. 7, the user interface 14 provides anindication of the alarm with the red light bar 52 and red coded systemstatus message box 46, indication of the particular condition and how tomanage the condition in the system status message box 46, and anindication of where to manage the condition on the touch screen with thecolor coded icon. Any combination of colors, color intensity, sounds,and text can be used in accordance with the present invention toidentify an alarm condition.

In FIGS. 9 and 10 another exemplary feature of the user interface 14 isillustrated. FIG. 9 shows user interface 14 in a state of alarm and withan indication of such alarm provided by illumination of the red lightbar 52 of the system status indicator 42. In accordance with the presentinvention, the system status message box 46 displays information aboutthe alarm and is preferably displayed with a corresponding red colorcode. In particular, the illustrated alarm of FIG. 26 is related to thestate of a clamp system and indicates that the clamp is closed.Accordingly, the system status message box 46 identifies the conditionand also provides information regarding how to manage the alarm bypressing the open clamp button 58 which is also preferably color codedred with the alarm color. Also illustrated is a clamp status button 60color-coded red and which is used to configure the clamp system. In FIG.10, a submenu 62 of the open clamp button 58 is shown which is activatedand displayed when the open clamp button 58 is pushed and which can beused to provide verification of the action of opening the clamp byselecting a confirm button 64 or a cancel button 66.

The present invention has now been described with reference to severalembodiments thereof. The entire disclosure of any patent or patentapplication identified herein is hereby incorporated by reference. Theforegoing detailed description and examples have been given for clarityof understanding only. No unnecessary limitations are to be understoodtherefrom. It will be apparent to those skilled in the art that manychanges can be made in the embodiments described without departing fromthe scope of the invention. Thus, the scope of the present inventionshould not be limited to the structures described herein, but only bythe structures described by the language of the claims and theequivalents of those structures.

What is claimed is:
 1. A method of managing a condition change of aperfusion system during cardiopulmonary bypass surgery, the methodcomprising the steps of: monitoring a perfusion control system duringcardiopulmonary bypass surgery by way of a user interface of theperfusion control system comprising a display screen, the display screenshowing a color coded system status bar that includes distinct barportions, with one bar portion for displaying a first color, a secondbar portion for displaying a second color, and a third bar portion fordisplaying a third color; displaying the first color within the firstportion of the color coded system status bar during normal operation ofthe perfusion system; receiving information indicative an occurrence ofa first system operational problem and a second system operationalproblem; prioritizing the first and second system operational problemssuch that one of the first and second operational problems is designatedas a highest priority system operational problem and the other of thefirst and second operational problems is designated as a next highestpriority system operational problem; displaying one of the second orthird color within the respective second or third bar portion based uponthe highest priority system operational problem, the color beingdisplayed indicating any one out of a plurality of system conditions ashave been prioritized according to a level of the system operationproblem as such system operational problems have been programmed intothe perfusion control system; displaying a first message indicative ofthe highest priority system operational problem within a distinct systemmessage box that is positioned separately from the status bar on thedisplay screen, thereby indicating a specific system operation problemout of the plurality of system conditions that have been prioritizedaccording to the level represented by the displayed color; andsubsequently displaying a second message indicative of the next highestpriority system operational problem within the distinct system messagebox upon correction of the highest priority system operational problem.2. The method of claim 1, wherein the first, second, and third colorscomprise green, yellow, and red, respectively.
 3. The method of claim 2,wherein red indicates an alarm condition requiring immediate correctiveaction.
 4. The method of claim 2, wherein yellow indicates an alertcondition requiring non-immediate corrective action.
 5. The method ofclaim 2, wherein green indicates absence of a requirement for correctiveaction.
 6. The method of claim 1, further comprising a step ofdisplaying a color coded system management icon on the display screenfor managing the displayed system operational problem.
 7. The method ofclaim 1, further comprising the step of displaying real time operatingdata indicators on the display screen.
 8. A perfusion control system anda user interface for managing a condition change of a perfusion systemduring cardiopulmonary bypass surgery, the user interface comprising: adisplay screen including a color coded system status bar that includesdistinct bar portions, with one bar portion for displaying a firstcolor, a second bar portion for displaying a second color, and a thirdbar portion for displaying a third color; the display screen furtherincluding a coded textual message portion that is positioned separatelyfrom the status bar on the display screen for providing informationrelated to a system operational problem, wherein each of the first,second, and third colors of the status bar indicate a distinct systemcondition; and the perfusion control system being programmed with systemoperational problems according to plural levels of severity with pluralsystem operational problems prioritized as of an alert level andassociated with the second color of the second bar portion and withplural operation problems prioritized as of an alarm level andassociated with the third color of the third bar portion, the perfusioncontrol system operatively connected with the display screen of the userinterface so that under normal operation conditions the first color isdisplayed in the first bar portion, under the alert level of systemoperational problems the second color is displayed in the second barportion and the coded textual message portion includes information of aspecific operational problem of the alert level, and under the alarmlevel of system operational problems the third color is displayed in thethird bar portion and the coded textual message portion includesinformation of a specific operational problem of the alarm level,wherein the perfusion control system is further programmed such thatupon occurrence of a plurality of system operational problems, thedisplay screen is prompted message in the coded textual message portionrelating to a highest priority operational problem, followed by thedisplay screen being prompted to display a second message in the codedtextual message portion relating to a next highest priority operationalproblem upon correction of the highest priority operational problem. 9.The user interface of claim 8, wherein the display further comprises oneor more color coded system management icons that are displayedpositioned separately from the status bar and separately from the codedtextual message portion on the display screen for managing a specificoperational problem based on the color coded system status bar under analert or alarm condition.
 10. The user interface of claim 8, furthercomprising real time operating data indicators displayed on the displayscreen.
 11. A pump console for use during cardiopulmonary bypasssurgery, the pump console comprising a base unit and the perfusioncontrol system with the user interface of claim 8, the base unitcomprising one or more interfaces for controlling pump speed, monitoringflow, and communicating with the user interface.
 12. The pump console ofclaim 11, further comprising one or more of an automated arterial lineocclusion system, level detectors operatively connected to a bloodreservoir, and a bubble detector system.
 13. A method of managing acondition change of a perfusion system during cardiopulmonary bypasssurgery, the method comprising the steps of: monitoring a perfusioncontrol system during cardiopulmonary bypass surgery by way of a userinterface of the perfusion control system comprising a display screen,the display screen showing a color coded system status bar that includesdistinct bar portions, with one bar portion for displaying a firstcolor, a second bar portion for displaying a second color, and a thirdbar portion for displaying a third color; displaying the first colorwithin the first portion of the color coded system status bar duringnormal operation of the perfusion system, and subsequently displayingone of the second or third color within the respective second or thirdbar portion upon an occurrence of a system operational problem, thecolor being displayed indicating any one out of a plurality of systemconditions as have been prioritized according to a level of the systemoperation problem as such system operational problems have beenprogrammed into the perfusion control system; displaying a messagewithin a distinct system message box that is positioned separately fromthe status bar on the display screen and thereby indicating a specificsystem operation problem out of the plurality of system conditions thathave been prioritized according to the level represented by thedisplayed color; and displaying a color coded system management iconthat is positioned separately from the status bar and separately fromthe system message box on the display screen for managing the displayedsystem operational problem based on the color coded system status barunder an alert or alarm condition.
 14. The method of claim 13, whereinthe first, second, and third colors comprise green, yellow, and red,respectively.
 15. The method of claim 14, wherein red indicates an alarmcondition requiring immediate corrective action.
 16. The method of claim14, wherein yellow indicates an alarm condition requiring non-immediatecorrective action.
 17. The method of claim 14, wherein green indicatesabsence of a requirement for corrective action.
 18. The method of claim13, wherein the step of displaying a color coded alarm condition on thedisplay screen comprises displaying textual information to identify thealarm condition.
 19. The method of claim 13, further comprising the stepof displaying real time operating data indicators on the display screen.